Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097630
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2004-11-24
Brief Title:
ABC Trial Awakening and Breathing Controlled
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Cognitive Impairment in the ICU Evaluation and Outcomes
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the impact of a new RNRRT Registered NurseRegistered Respiratory Therapist directed 2-step protocol to wean patients off of a ventilator This protocol involves daily attempts to halt sedation spontaneous awakening trials combined with daily assessments of patients while they are breathing on their own spontaneous breathing trials
Detailed Description:
Unnecessary delays in removing patients from mechanical ventilation increase morbidity mortality and cost According to recently published guidelines the current standard of care for weaning involves the daily assessment of patients while they are breathing spontaneously also known as spontaneous breathing trials SBT While there are important data to support a daily cessation of sedatives and analgesics to the point of patient awakening the benefit of combining such a daily spontaneous awakening trial SAT and an SBT is not known
This multi-center randomized controlled trial will test whether a 2-step process of weaning that combines a daily awakening trial achieved by stopping all sedatives and narcotics every morning with a daily spontaneous breathing trial is superior to the current standard of care
The number of days the patient is able to live off the ventilator is the primary question being studied The secondary questions include the number of days the patient is in Intensive Care Unit ICU and the hospital the complications associated with being on the ventilator such as the duration and severity of delirium and coma and in-hospital and one-year mortality Also cognitive psychological and functionalquality of life outcomes will be measured at discharge and 3 and 12 months later
In addition the study will measure plasma drug levels twice daily on five sequential days within 30 minutes of testing with highly reliable and well validated instruments to measure sedation level ie RASS and delirium ie CAM-ICU
This multi-center randomized controlled trial will test whether a 2-step process of weaning that combines a daily awakening trial achieved by stopping all sedatives and narcotics every morning with a daily spontaneous breathing trial is superior to the current standard of care
The number of days the patient is able to live off the ventilator is the primary question being studied The secondary questions include the number of days the patient is in Intensive Care Unit ICU and the hospital the complications associated with being on the ventilator such as the duration and severity of delirium and coma and in-hospital and one-year mortality Also cognitive psychological and functionalquality of life outcomes will be measured at discharge and 3 and 12 months later
In addition the study will measure plasma drug levels twice daily on five sequential days within 30 minutes of testing with highly reliable and well validated instruments to measure sedation level ie RASS and delirium ie CAM-ICU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K23AG001023-04 | NIH | None | httpsreporternihgovquickSearch5K23AG001023-04 |